Prone PositionNCT06580522
The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms
A study testing Prone Position Group and Supine Position Group in people with Prone Position and Supine Position, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Prone Position, Supine Position, Child
- What is being tested?
- Prone Position Group and Supine Position Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 6 months and 6 years of age
- Being monitored for respiratory diseases
- Weaning from noninvasive mechanical ventilation during the research process
- Body temperature within the normal range (36 centigrade-37,5 centigrade)
- Verbal and written consent to participate in the study given by their parents
Who cannot join
- Congenital anomaly
- Surgical intervention that prevents supine/prone positioning
- Development of pneumothorax during research
- Hypoxia during the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul
About this study
The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.
- Conditions
- Prone Position, Supine Position, Child
- Being tested
- Prone Position Group, Supine Position Group
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Position GroupOther
After the children in the prone position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were prone positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure.
Supine Position GroupOther
After the children in the supine position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were supine positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Prone Position Group | Experimental | Children in this group were given the prone position after weaning from noninvasive mechanical ventilation and its effect on the physiologic symptoms of the children was examined. Receives: Other: Prone Position Group |
| Supine Position Group | Experimental | Supine position group children were given supine position after weaning from noninvasive mechanical ventilation and the effects on physiologic symptoms were examined. Receives: Other: Supine Position Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse changes in children after weaning from noninvasive mechanical ventilation
Changes in the pulse rate of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to the children after weaning from noninvasive mechanical ventilation. The changes in the pulse rate values of the children between the age groups in the study in terms of minutes/pulse rate and the difference values between them according to minutes will be examined.
Measured: 120 minutes after weaning from noninvasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Mar 2023
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
- Investigators
- Duygu Gözen, Prof.Dr., Study director, Koç Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580522
- Sponsor's protocol ID
- 2023/30
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms
- ClinicalTrials.gov ID
- NCT06580522
- Acronym / sponsor ID
- 2023/30
- Conditions
- Prone Position, Supine Position, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Position Group | Experimental | Other: Prone Position GroupChildren in this group were given the prone position after weaning from noninvasive mechanical ventilation and its effect on the physiologic symptoms of the children was examined. |
| Supine Position Group | Experimental | Other: Supine Position GroupSupine position group children were given supine position after weaning from noninvasive mechanical ventilation and the effects on physiologic symptoms were examined. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 6 months and 6 years of age
- Being monitored for respiratory diseases
- Weaning from noninvasive mechanical ventilation during the research process
- Body temperature within the normal range (36 centigrade-37,5 centigrade)
- Verbal and written consent to participate in the study given by their parents
Key exclusion criteria (4 listed)
- Congenital anomaly
- Surgical intervention that prevents supine/prone positioning
- Development of pneumothorax during research
- Hypoxia during the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone Position GroupAfter the children in the prone position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were prone positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure. | Other | Prone Position Group |
| Supine Position GroupAfter the children in the supine position group were weaned from noninvasive mechanical ventilation according and started to breathe spontaneously, they were supine positioned and monitored for 120 minutes (2 hours) every 20 minutes (0.min, 20.min, 40.min, 60.min, 80.min, 100.min, 120.min) with a head-monitor for peak heart rate, oxygen saturation, respiratory rate and blood pressure. | Other | Supine Position Group |
Primary outcome
Pulse changes in children after weaning from noninvasive mechanical ventilation
Time frame: 120 minutes after weaning from noninvasive mechanical ventilation
Changes in the pulse rate of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to the children after weaning from noninvasive mechanical ventilation. The changes in the pulse rate values of the children between the age groups in the study in terms of minutes/pulse rate and the difference values between them according to minutes will be examined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Gözen, Prof.Dr. study director
Koç Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position Group and Supine Position Group in people with Prone Position and Supine Position, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse changes in children after weaning from noninvasive mechanical ventilation (time frame: 120 minutes after weaning from noninvasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.